|
Exhibit
10.1
EXECUTION VERSION
ASSET PURCHASE
AGREEMENT
BY AND BETWEEN
PDL BIOPHARMA,
INC.,
a Delaware
corporation
and
OTSUKA PHARMACEUTICAL CO.,
LTD.,
a Japanese
corporation
Dated as of December 14,
2007
TABLE OF
CONTENTS
|
|
|
|
|
|
|
| |
|
|
|
Page |
| ARTICLE 1 |
|
DEFINITIONS |
|
1 |
|
|
|
|
|
|
1.1 |
|
“Accounts Payable” |
|
1 |
|
|
|
|
|
|
1.2 |
|
“Accounts Receivable” |
|
1 |
|
|
|
|
|
|
1.3 |
|
“Affiliate” |
|
1 |
|
|
|
|
|
|
1.4 |
|
“API” |
|
1 |
|
|
|
|
|
|
1.5 |
|
“Assets” |
|
1 |
|
|
|
|
|
|
1.6 |
|
“Assumed Contracts” |
|
1 |
|
|
|
|
|
|
1.7 |
|
“Books and Records” |
|
1 |
|
|
|
|
|
|
1.8 |
|
“Business” |
|
2 |
|
|
|
|
|
|
1.9 |
|
“Buyer Indemnitee(s)” |
|
2 |
|
|
|
|
|
|
1.10 |
|
“Claim” |
|
2 |
|
|
|
|
|
|
1.11 |
|
“Clinical Data” |
|
2 |
|
|
|
|
|
|
1.12 |
|
“Closing” |
|
2 |
|
|
|
|
|
|
1.13 |
|
“Closing Date” |
|
2 |
|
|
|
|
|
|
1.14 |
|
“Closing Date Inventory Value Schedule” |
|
2 |
|
|
|
|
|
|
1.15 |
|
“Confidential Information” |
|
2 |
|
|
|
|
|
|
1.16 |
|
“Confidentiality Agreement” |
|
2 |
|
|
|
|
|
|
1.17 |
|
“Customer Orders” |
|
2 |
|
|
|
|
|
|
1.18 |
|
“Drug Product” |
|
2 |
|
|
|
|
|
|
1.19 |
|
“Effective Date” |
|
2 |
|
|
|
|
|
|
1.20 |
|
“Excluded Assets” |
|
2 |
|
|
|
|
|
|
1.21 |
|
“Expiration Date” |
|
2 |
|
|
|
|
|
|
1.22 |
|
“FDA” |
|
2 |
|
|
|
|
|
|
1.23 |
|
“FD&C Act” |
|
2 |
|
|
|
|
|
|
1.24 |
|
“Governmental Entity” |
|
2 |
|
|
|
|
|
|
1.25 |
|
“HSR” |
|
2 |
|
|
|
|
|
|
1.26 |
|
“IND” |
|
3 |
|
|
|
|
|
|
1.27 |
|
“Knowledge” |
|
3 |
|
|
|
|
|
|
1.28 |
|
“Liabilities” |
|
3 |
|
|
|
|
|
|
1.29 |
|
“Licensed IP Rights” |
|
3 |
|
|
|
|
|
|
1.30 |
|
“Material Adverse Change” and “Material
Adverse Effect” |
|
3 |
TABLE OF
CONTENTS
(continued)
|
|
|
|
|
|
|
| |
|
|
|
|
|
Page |
|
|
1.31 |
|
“Marketing and Promotional Documents” |
|
3 |
|
|
|
|
|
|
1.32 |
|
“NDA” |
|
3 |
|
|
|
|
|
|
1.33 |
|
“Non Product-Specific Manufacturing
Information” |
|
3 |
|
|
|
|
|
|
1.34 |
|
“Non-U.S. Marketing Approvals” |
|
3 |
|
|
|
|
|
|
1.35 |
|
“Notice of Objection” |
|
3 |
|
|
|
|
|
|
1.36 |
|
“Packaged Product” |
|
4 |
|
|
|
|
|
|
1.37 |
|
“Packaging Inventory” |
|
4 |
|
|
|
|
|
|
1.38 |
|
“Patents” |
|
4 |
|
|
|
|
|
|
1.39 |
|
“Product” |
|
4 |
|
|
|
|
|
|
1.40 |
|
“Product Inventory” |
|
4 |
|
|
|
|
|
|
1.41 |
|
“Product-Specific Manufacturing
Information” |
|
4 |
|
|
|
|
|
|
1.42 |
|
“Product Specifications” |
|
4 |
|
|
|
|
|
|
1.43 |
|
“Purchase Price” |
|
4 |
|
|
|
|
|
|
1.44 |
|
“Raw Materials and WIP” |
|
4 |
|
|
|
|
|
|
1.45 |
|
“Registrations” |
|
4 |
|
|
|
|
|
|
1.46 |
|
“Research and Development Materials” |
|
4 |
|
|
|
|
|
|
1.47 |
|
“SEC” |
|
4 |
|
|
|
|
|
|
1.48 |
|
“Seller Indemnitees” |
|
4 |
|
|
|
|
|
|
1.49 |
|
“Shared Contracts” |
|
4 |
|
|
|
|
|
|
1.50 |
|
“Tangible Assets |
|
4 |
|
|
|
|
|
|
1.51 |
|
“Tax” and “Taxes” |
|
4 |
|
|
|
|
|
|
1.52 |
|
“Territory” |
|
5 |
|
|
|
|
|
|
1.53 |
|
“Third Party Accounting Firm” |
|
5 |
|
|
|
|
|
|
1.54 |
|
“Trademarks” |
|
5 |
|
|
|
|
|
|
1.55 |
|
“Trademark Registrations” |
|
5 |
|
|
|
|
|
|
1.56 |
|
“Transition Services Agreement” |
|
5 |
|
|
|
|
|
|
1.57 |
|
“Worldwide Safety Reports” |
|
5 |
|
|
|
|
ARTICLE 2
|
|
TRANSFER OF ASSETS; LICENSE AND SUBLICENSE |
|
5 |
|
|
|
|
|
|
2.1 |
|
Purchase
and Sale of Assets |
|
5 |
|
|
|
|
|
|
|
|
(a) Patents
|
|
5 |
|
|
|
|
|
|
|
|
(b) Licensed IP
and Know-How
|
|
5 |
|
|
|
|
|
|
|
|
(c) Trademark
Registrations
|
|
6 |
ii
TABLE OF
CONTENTS
(continued)
|
|
|
|
|
|
|
| |
|
|
|
|
|
Page |
|
|
|
|
(d) Copyrights
|
|
6 |
|
|
|
|
|
|
|
|
(e) Registrations
|
|
6 |
|
|
|
|
|
|
|
|
(f) Product-Specific Manufacturing
Information
|
|
6 |
|
|
|
|
|
|
|
|
(g) Non
Product-Specific Manufacturing Information
|
|
6 |
|
|
|
|
|
|
|
|
(h) Research and
Development Materials
|
|
7 |
|
|
|
|
|
|
|
|
(i) Marketing and Promotional
Documents
|
|
7 |
|
|
|
|
|
|
|
|
(j) Worldwide Safety
Reports
|
|
7 |
|
|
|
|
|
|
|
|
(k) Clinical
Data
|
|
7 |
|
|
|
|
|
|
|
|
(l) Tangible Assets
|
|
7 |
|
|
|
|
|
|
|
|
(m) Domain
Names
|
|
7 |
|
|
|
|
|
|
|
|
(n) Product
Inventory
|
|
7 |
|
|
|
|
|
|
|
|
(o) Packaging
Inventory
|
|
7 |
|
|
|
|
|
|
|
|
(p) Raw Materials
and WIP
|
|
8 |
|
|
|
|
|
|
|
|
(q) Assumed
Contracts
|
|
8 |
|
|
|
|
|
|
|
|
(r) Books
and Records
|
|
8 |
|
|
|
|
|
|
|
|
(s) Customer
Orders
|
|
8 |
|
|
|
|
|
|
2.2 |
|
Excluded
Assets |
|
8 |
|
|
|
|
|
|
2.3 |
|
Assumed
Liabilities |
|
8 |
|
|
|
|
|
|
2.4 |
|
Excluded
Liabilities |
|
9 |
|
|
|
|
|
|
2.5 |
|
Risk of
Loss |
|
9 |
|
|
|
|
|
|
2.6 |
|
Taxes |
|
10 |
|
|
|
|
ARTICLE 3
|
|
CONSIDERATION |
|
10 |
|
|
|
|
|
|
3.1 |
|
Purchase
Price |
|
10 |
|
|
|
|
|
|
3.2 |
|
Method of
Payment |
|
10 |
|
|
|
|
|
|
3.3 |
|
Allocation of Purchase Price |
|
10 |
|
|
|
|
|
|
3.4 |
|
Product
Inventory, Raw Materials and WIP Adjustment |
|
10 |
|
|
|
|
ARTICLE 4
|
|
CLOSING |
|
11 |
|
|
|
|
|
|
4.1 |
|
Closing |
|
11 |
|
|
|
|
|
|
4.2 |
|
Actions
at Closing |
|
11 |
|
|
|
|
|
|
|
|
(a) Deliveries by
Seller at Closing
|
|
11 |
|
|
|
|
|
|
|
|
(b) Deliveries by
Buyer at Closing
|
|
13 |
iii
TABLE OF
CONTENTS
(continued)
|
|
|
|
|
|
|
| |
|
|
|
|
|
Page |
|
ARTICLE 5
|
|
EMPLOYMENT MATTERS |
|
13 |
|
|
|
|
|
|
5.1 |
|
Employees |
|
13 |
|
|
|
|
ARTICLE 6
|
|
REPRESENTATIONS AND WARRANTIES OF SELLER |
|
14 |
|
|
|
|
|
|
6.1 |
|
Organization and Authority |
|
14 |
|
|
|
|
|
|
6.2 |
|
No
Violation or Conflict |
|
15 |
|
|
|
|
|
|
6.3 |
|
Consents
and Approvals |
|
15 |
|
|
|
|
|
|
6.4 |
|
Title to
Assets |
|
15 |
|
|
|
|
|
|
6.5 |
|
Patents |
|
15 |
|
|
|
|
|
|
6.6 |
|
Trademarks |
|
16 |
|
|
|
|
|
|
6.7 |
|
Registrations |
|
16 |
|
|
|
|
|
|
6.8 |
|
Assumed
Contracts |
|
16 |
|
|
|
|
|
|
6.9 |
|
Manufacturing |
|
16 |
|
|
|
|
|
|
6.10 |
|
Registrations; Regulatory Matters |
|
17 |
|
|
|
|
|
|
6.11 |
|
Regulatory Status of Product |
|
17 |
|
|
|
|
|
|
6.12 |
|
Product
Net Sales |
|
17 |
|
|
|
|
|
|
6.13 |
|
Violations of Law |
|
17 |
|
|
|
|
|
|
6.14 |
|
Litigation |
|
17 |
|
|
|
|
|
|
6.15 |
|
Taxes |
|
18 |
|
|
|
|
|
|
6.16 |
|
Customers
and Suppliers |
|
18 |
|
|
|
|
|
|
6.17 |
|
Inventory |
|
18 |
|
|
|
|
|
|
6.18 |
|
Employees |
|
18 |
|
|
|
|
|
|
6.19 |
|
Insurance |
|
19 |
|
|
|
|
|
|
6.20 |
|
Packaging
Inventory |
|
19 |
|
|
|
|
|
|
6.21 |
|
Brokers
and Finders |
|
19 |
|
|
|
|
|
|
6.22 |
|
Sufficiency |
|
19 |
|
|
|
|
|
|
6.23 |
|
No
Implied Warranty |
|
19 |
|
|
|
|
ARTICLE 7
|
|
REPRESENTATIONS AND WARRANTIES OF BUYER |
|
20 |
|
|
|
|
|
|
7.1 |
|
Organization and Authority |
|
20 |
|
|
|
|
|
|
7.2 |
|
No
Conflict or Violation |
|
20 |
|
|
|
|
|
|
7.3 |
|
Consents
and Approvals |
|
20 |
|
|
|
|
|
|
7.4 |
|
Cash
Resources |
|
21 |
|
|
|
|
|
|
7.5 |
|
Litigation |
|
21 |
iv
TABLE OF
CONTENTS
(continued)
|
|
|
|
|
|
|
| |
|
|
|
|
|
Page |
|
|
7.6 |
|
Brokers
and Finders |
|
21 |
|
|
|
|
|
|
7.7 |
|
Buyer Due
Diligence |
|
21 |
|
|
|
|
ARTICLE 8
|
|
PRE-CLOSING COVENANTS OF SELLER |
|
21 |
|
|
|
|
|
|
8.1 |
|
Governmental Filings |
|
21 |
|
|
|
|
|
|
8.2 |
|
Conduct
of Business |
|
21 |
|
|
|
|
|
|
8.3 |
|
Obtaining
Necessary Consents |
|
21 |
|
|
|
|
|
|
8.4 |
|
Shared
Contracts |
|
22 |
|
|
|
|
|
|
8.5 |
|
No
Solicitation |
|
22 |
|
|
|
|
|
|
8.6 |
|
Access |
|
22 |
|
|
|
|
ARTICLE 9
|
|
CONDITIONS TO CLOSING |
|
23 |
|
|
|
|
|
|
9.1 |
|
Conditions to Obligations of Buyer |
|
23 |
|
|
|
|
|
|
9.2 |
|
Conditions to Obligations of Seller |
|
23 |
|
|
|
|
ARTICLE 10
|
|
POST - CLOSING COVENANTS |
|
23 |
|
|
|
|
|
|
10.1 |
|
Further
Assurances |
|
23 |
|
|
|
|
|
|
10.2 |
|
Transfer
of Registrations; Interim Responsibility |
|
23 |
|
|
|
|
|
|
10.3 |
|
Communication With Agencies |
|
24 |
|
|
|
|
|
|
10.4 |
|
Federal
Supply Schedule |
|
24 |
|
|
|
|
|
|
10.5 |
|
Adverse
Experience Reporting |
|
24 |
|
|
|
|
|
|
10.6 |
|
Promotion, Marketing and Labeling |
|
25 |
|
|
|
|
|
|
10.7 |
|
Medical
Inquiries |
|
26 |
|
|
|
|
|
|
10.8 |
|
Non-Use
of Trademarks |
|
26 |
|
|
|
|
|
|
10.9 |
|
Documents |
|
26 |
|
|
|
|
|
|
10.10 |
|
Governmental Inspections |
|
26 |
|
|
|
|
|
|
10.11 |
|
Intellectual Property Maintenance |
|
27 |
|
|
|
|
|
|
10.12 |
|
Insurance |
|
27 |
|
|
|
|
|
|
10.13 |
|
Payments
from Third Parties |
|
27 |
|
|
|
|
|
|
10.14 |
|
Distribution of Products |
|
27 |
|
|
|
|
|
|
10.15 |
|
Product
Returns, Chargebacks and Rebates |
|
28 |
|
|
|
|
|
|
10.16 |
|
Additional Assets |
|
28 |
|
|
|
|
|
|
10.17 |
|
Bulk
Transfer Laws |
|
28 |
|
|
|
|
ARTICLE 11
|
|
CONFIDENTIALITY |
|
28 |
|
|
|
|
|
|
11.1 |
|
Confidentiality |
|
28 |
v
TABLE OF
CONTENTS
(continued)
|
|
|
|
|
|
|
|
|
11.2 |
|
Publicity |
|
29 |
|
|
|
|
ARTICLE 12
|
|
TERM AND TERMINATION |
|
29 |
|
|
|
|
ARTICLE 13
|
|
INDEMNIFICATION |
|
30 |
|
|
|
|
|
|
13.1 |
|
Indemnification by Buyer |
|
30 |
|
|
|
|
|
|
13.2 |
|
Indemnification by Seller |
|
30 |
|
|
|
|
|
|
13.3 |
|
Claims |
|
31 |
|
|
|
|
|
|
13.4 |
|
Limitation; Exclusivity |
|
31 |
|
|
|
|
ARTICLE 14
|
|
MISCELLANEOUS |
|
31 |
|
|
|
|
|
|
14.1 |
|
Non-Survival of Representations and Warranties |
|
31 |
|
|
|
|
|
|
14.2 |
|
No Third
Party Beneficiaries |
|
31 |
|
|
|
|
|
|
14.3 |
|
Force
Majeure |
|
31 |
|
|
|
|
|
|
14.4 |
|
Governing
Law; Jurisdiction; Dispute Resolution and Arbitration |
|
32 |
|
|
|
|
|
|
14.5 |
|
Severability |
|
32 |
|
|
|
|
|
|
14.6 |
|
Entire
Agreement |
|
33 |
|
|
|
|
|
|
14.7 |
|
Amendment |
|
33 |
|
|
|
|
|
|
14.8 |
|
Notices |
|
33 |
|
|
|
|
|
|
14.9 |
|
Assignment |
|
34 |
|
|
|
|
|
|
14.10 |
|
No
Agency |
|
34 |
|
|
|
|
|
|
14.11 |
|
Construction |
|
34 |
|
|
|
|
|
|
14.12 |
|
Payment
of Expenses |
|
34 |
|
|
|
|
|
|
14.13 |
|
Counterparts |
|
34 |
vi
LIST OF EXHIBITS,
ATTACHMENT AND SCHEDULES
|
|
|
| EXHIBITS |
|
|
|
|
| Exhibit
A |
|
General
Assignment and Bill of Sale |
| Exhibit
B |
|
Assignment and Assumption Agreement |
| Exhibit
C |
|
Domain
Name Assignment Agreement |
| Exhibit
D |
|
Patent
Assignment Agreement |
| Exhibit
E |
|
Trademark
Assignment Agreement |
| Exhibit
F |
|
Transition Services Agreement |
| Exhibit
G |
|
Form of
Third Party Consent to Assignment of Assumed Contracts |
| Exhibit
H |
|
Form of
Third Party Notification Letter |
|
|
| ATTACHMENTS |
|
|
|
|
| Attachment
1.42(a) |
|
Product
Specifications for bulk API |
| Attachment
1.42(b) |
|
Product
Specification for Drug Product |
| Attachment
1.44 |
|
List of
Raw Materials and WIP |
| Attachment
2.1(a) |
|
List of
Patents |
| Attachment
2.1(b) |
|
List of
Licensed IP Rights |
| Attachment
2.1(c) |
|
List of
Trademark Registrations |
| Attachment
2.1(e) |
|
List of
Registrations |
| Attachment
2.1(l) |
|
List of
Tangible Assets |
| Attachment
2.1(m) |
|
List of
Domain Names |
| Attachment
2.1(q)(1) |
|
List of
Shared Contracts |
| Attachment
2.1(q)(2) |
|
List of
Assumed Contracts |
| Attachment
4.2(a) |
|
List of
Third Party Consents |
| Attachment
5.1(a) |
|
Business
Employees |
|
| DISCLOSURE SCHEDULES |
|
|
| Schedule
6.3 |
|
Consents
and Approvals |
| Schedule
6.4 |
|
Title to
Assets |
| Schedule
6.5 |
|
Patents |
| Schedule
6.6 |
|
Trademarks |
| Schedule
6.7 |
|
Registrations |
| Schedule
6.8(a) |
|
Default
under Assumed Contracts and Shared Contracts |
| Schedule
6.8(b) |
|
Third
Party Consents |
| Schedule
6.9 |
|
Manufacturing |
| Schedule
6.10 |
|
Registrations; Regulatory Matters |
| Schedule
6.11 |
|
Regulatory Status of Product |
| Schedule
6.12 |
|
Product
Net Sales |
| Schedule
6.14 |
|
Litigation |
| Schedule
6.16(a) |
|
Customers
and Suppliers |
| Schedule
6.16(b) |
|
Notice
from Customers and Suppliers |
| Schedule
6.17 |
|
Inventory |
|
|
|
| Schedule
6.18 |
|
Employees |
| Schedule
6.19 |
|
Insurance |
| Schedule
6.20 |
|
Packaging
Inventory |
| Schedule
6.21 |
|
Brokers
and Finders (Seller) |
|
|
| SCHEDULES |
|
|
|
|
| Schedule
7.6 |
|
Brokers
and Finders (Buyer) |
| Schedule
8.4 |
|
Shared
Contracts |
ii
ASSET PURCHASE
AGREEMENT
This Asset Purchase Agreement
(this “ Agreement ”) is entered into as of
December 14, 2007 (the “ Effective Date ”)
between PDL BioPharma, Inc., a Delaware corporation (“
Seller ”) and Otsuka Pharmaceutical Co., Ltd., a
Japanese corporation (“ Buyer ”).
RECITALS
A. Seller owns certain rights
and assets related to the IV Busulfex ® (busulfan) product.
B. Seller desires to sell,
and Buyer wishes to acquire, all right, title and interest in and
to the Assets (as defined below) used in the Business (as defined
below), upon the terms and conditions set forth in this Agreement,
in exchange for consideration consisting of cash and the assumption
of certain Liabilities in connection with the Business, and other
terms and conditions as set forth in this Agreement.
AGREEMENT
NOW, THEREFORE, in
consideration of the mutual covenants and agreements contained in
this Agreement, and for other good and valuable consideration, the
sufficiency and receipt of which are hereby acknowledged, the
parties to this Agreement agree as follows:
ARTICLE 1
DEFINITIONS
1.1 “ Accounts
Payable ” shall mean all of Seller’s trade accounts
payable, and all notes payable by Seller created or arising in
respect of the Product.
1.2 “ Accounts
Receivable ” shall mean all of Seller’s trade
accounts receivable, and all notes receivable or evidences of
indebtedness payable to Seller created or arising in respect of the
sale of the Product.
1.3 “ Affiliate
” with respect to any party means any entity that is directly
or indirectly controlling, controlled by or under common control
with such party.
1.4 “ API
” shall mean the active pharmaceutical ingredient
busulfan.
1.5 “ Assets
” shall have the meaning given in Article 2.
1.6 “ Assumed
Contracts ” shall have the meaning given in
Section 2.1(q) and shall include the agreements, purchase
orders and change orders listed in Attachment 2.1(q)(2)
.
1.7 “ Books and
Records ” shall mean all pricing lists, material customer
correspondence and related material books and records used solely
and specifically with respect to the Business in the Territory by
Seller or any of Seller’s Affiliates.
1
1.8 “ Business
” shall mean the business as conducted at the Closing Date by
Seller of using, making or having made, selling, marketing and
supporting the Product.
1.9 “ Buyer
Indemnitee(s) ” shall have the meaning given in
Section 13.2.
1.10 “ Claim
” shall have the meaning given in
Section 13.3.
1.11 “ Clinical
Data ” shall have the meaning given in
Section 2.1(k).
1.12 “ Closing
” shall have the meaning given in
Section 4.1.
1.13 “ Closing
Date ” shall have the meaning given in
Section 4.1.
1.14 “ Closing Date
Inventory Value Schedule ” shall have the meaning given
in Section 3.1.
1.15 “ Confidential
Information ” shall have the meaning ascribed to it in
the Confidentiality Agreement.
1.16 “
Confidentiality Agreement ” shall mean that certain
Mutual Confidentiality Agreement between Buyer and Seller dated
September 6, 2007.
1.17 “ Customer
Orders ” mean orders for Packaged Product from customers
of Seller or any of Seller’s Affiliates in the
Territory.
1.18 “ Drug
Product ” shall mean labeled or unlabelled vials
containing API.
1.19 “ Effective
Date ” shall mean the date first set forth in the opening
paragraph of this Agreement.
1.20 “ Excluded
Assets ” shall have the meaning given in
Section 2.2.
1.21 “ Expiration
Date ” shall have the meaning given in
Section 11.1.
1.22 “ FDA
” shall mean the United States Food and Drug Administration,
or any successor agency or entity thereto that may be established
hereafter which has the responsibilities with respect to
pharmaceutical products such as the Product.
1.23 “ FD&C
Act ” shall mean the Federal Food, Drug and Cosmetic Act,
21 USC § 321 et seq .
1.24 “ Governmental
Entity ” shall mean any court, tribunal, arbitrator,
authority, agency, commission, regulatory, official or other
instrumentality of the government of the United States or of any
foreign country, any state or any political subdivision of any such
government (whether state, provincial, county, city, municipal or
otherwise).
1.25 “ HSR
” shall mean the United States Hart-Scott-Rodino Antitrust
Improvements Act of l976, as amended, and related rules.
2
1.26 “ IND
” shall mean investigational new drug application number IND
46,232, initially filed September 16, 1994.
1.27 “ Knowledge
” shall mean, whenever any representation or warranty is made
by Seller or Buyer “to the Knowledge” of the Seller or
Buyer, (i) the actual knowledge of the officers of the Seller
or Buyer, respectively, and (ii) the knowledge that any such
person referenced in clause (i) hereof, as a prudent business
person, would have obtained in the usual course of the performance
of his or her professional responsibilities to such
party.
1.28 “
Liabilities ” shall mean liabilities of any kind or
nature, primary or secondary, direct or indirect, absolute or
contingent, known or unknown, liquidated or unliquidated, including
but not limited to any liabilities for claims of product liability,
personal injury or death, liability in tort or contract (including
unripened liabilities due to past actions or sales), indebtedness,
and any FDA or other Governmental Entity action or notification,
and all costs and expenses (including reasonable attorneys’
fees), incurred in connection with the defense of any such
claims.
1.29 “ Licensed IP
Rights ” shall have the meaning given in
Section 2.1(b).
1.30 “ Material
Adverse Change ” and “ Material Adverse
Effect ” shall mean any event or situation that has a
material adverse change or effect, respectively, on the operations,
assets, Liabilities, results of operations, cash flows or financial
condition, or relations with material customers or material
suppliers, of the Business, taken as a whole, other than any such
change or effect resulting from or arising in connection with
(i) the announcement, performance or pendency of this
Agreement or the transactions contemplated hereby,
(ii) changes or conditions affecting the pharmaceutical
industry, generally, (iii) changes in economic, regulatory or
political conditions generally, (iv) changes in financial
markets, including prevailing interest rates or market conditions;
(v) developments or announcements, including product approvals
and clinical trial results with respect to competitive or
potentially competitive therapies or products,
(vi) resignations or departures of employees engaged in the
Business, (vii) fluctuations in foreign currency exchange
rates, (viii) any failure to meet internal or published
projections, estimates or forecasts of revenues, earnings,
development timelines or other measures of financial or operating
performance for any period, (ix) changes in applicable laws or
interpretations thereof by Governmental Entities or
(x) changes or effects that are the result of actions taken by
Buyer that have an effect on the Business.
1.31 “ Marketing and
Promotional Documents ” shall have the meaning given in
Section 2.1(i).
1.32 “ NDA
” shall mean new drug application number NDA 20-954,
initially approved February 4, 1999.
1.33 “ Non
Product-Specific Manufacturing Information ” shall have
the meaning given in Section 2.1(g).
1.34 “ Non-U.S.
Marketing Approvals ” shall have the meaning given in
Section 6.10.
1.35 “ Notice of
Objection ” shall have the meaning given in
Section 3.4.
3
1.36 “ Packaged
Product ” shall mean Product in the Product Inventory
purchased by Buyer hereunder that is packaged and labeled for sale
to the end user.
1.37 “ Packaging
Inventory ” shall have the meaning given in
Section 2.1(o).
1.38 “ Patents
” shall have the meaning given in
Section 2.1(a).
1.39 “ Product
” shall mean each presentation of any pharmaceutical
preparation (including formulation changes and production
intermediates) containing the API, whether registered, marketed or
in development by Seller, as of the Closing Date, including Product
marketed under the name IV Busulfex ® (busulfan).
1.40 “ Product
Inventory ” shall mean all of the inventory owned by
Seller of bulk API, Packaged Product and Drug Product, in existence
as of the Closing each of which shall have a remaining shelf-life
of at least six (6) months as of the Closing Date.
1.41 “
Product-Specific Manufacturing Information ” shall
have the meaning given in Section 2.1(f).
1.42 “ Product
Specifications ” shall mean the specifications for bulk
API, and for Drug Product, as set forth in Attachments 1.42
(a) and (b) , respectively.
1.43 “ Purchase
Price ” shall have the meaning given in
Section 3.1.
1.44 “ Raw Materials
and WIP ” shall mean all of the raw materials and work in
progress owned by Seller for use in the manufacture of the Product,
in existence as of the Closing, as identified in Attachment
1.44 , each of which shall have a remaining shelf-life of at
least six (6) months as of the Closing Date.
1.45 “
Registrations ” shall have the meaning given in
Section 2.1(e).
1.46 “ Research and
Development Materials ” shall have the meaning given in
Section 2.1(h).
1.47 “ SEC
” shall mean the United States Securities and Exchange
Commission.
1.48 “ Seller
Indemnitees ” shall have the meaning given in
Section 13.1.
1.49 “ Shared
Contracts ” shall mean contracts and agreements to which
Seller is a party which relate to the Product or the Business, but
also relate to other products and businesses of Seller.
1.50 “ Tangible
Assets ” shall have the meaning given in
Section 2.1(l).
1.51 “ Tax
” and “ Taxes ” shall mean all present or
future taxes, charges, fees, levies, duties or other assessments
including, without limitation, income, excise, property, value
added, real estate, sales, payroll, transfer, social security and
franchise taxes imposed by any federal, state, county, or local
government, or a subdivision or agency thereof. Such term shall
include any interest, penalties, or additions payable in connection
with such taxes, charges, fees, levies, duties, or other
assessments.
4
1.52 “ Territory
” shall mean all the countries in the world.
1.53 “ Third Party
Accounting Firm ” shall have the meaning given in
Section 3.4.
1.54 “
Trademarks ” shall mean all trademarks, service marks,
trade names, names, slogans, taglines, logos, design marks, trade
dress, product designs, and product packaging, including all
applications for and registrations of the foregoing, and including
those at common law that are related to the Product.
1.55 “ Trademark
Registrations ” shall have the meaning given in
Section 2.1(c).
1.56 “ Transition
Services Agreement ” shall mean the agreement entered
into by Buyer and Seller relating to the transition of the
Business, whereby Seller shall provide certain regulatory, supply
chain management, intellectual property, product development and
other services to Buyer, to the extent and for the periods of time
and at the costs as specified therein.
1.57 “ Worldwide
Safety Reports ” shall have the meaning given in
Section 2.1(j).
ARTICLE 2
TRANSFER OF ASSETS;
LICENSE AND SUBLICENSE
2.1 Purchase and Sale of
Assets . Subject to the terms and conditions of this Agreement,
Seller shall sell, transfer, assign, convey, deliver, license or
sublicense, as specified below, to Buyer; or shall cause to be
sold, transferred, assigned, conveyed, delivered, licensed or
sublicensed, as specified below, to Buyer, and Buyer shall acquire
all of Seller’s right, title and interest in and to the
property and assets of Seller identified in this Section 2.1
(collectively, the “ Assets ”).
(a) Patents . Upon
Closing, Seller shall sell, transfer, assign, convey and deliver;
or shall cause to be sold, transferred, assigned, conveyed and
delivered to Buyer, all of Seller’s rights, title and
interest in and to the patent filings listed in Attachment
2.1(a) (the “ Patents ”), including any
patents of addition, re-examinations, reissues, extensions, granted
supplementary protection certifications, substitutions,
confirmations, registrations, revalidations, revisions, additions
and the like, of or to said Patents and any and all divisionals,
continuations and continuations-in-part, and any patents issuing
therefrom. Seller hereby retains a royalty-free right and license,
including the right to sublicense, under the Patents, solely to the
extent necessary for, and solely for the purposes of, performing
Seller’s obligations under this Agreement and the Transition
Services Agreement and only until the completion of Seller’s
obligations hereunder and thereunder.
(b) Licensed IP and
Know-How . Upon Closing, and Buyer’s assumption of the
Assumed Contracts, Seller shall transfer, assign, convey and
deliver; or shall cause to be sold, transferred, assigned, conveyed
and delivered to Buyer, all of Seller’s rights under the
patent rights listed in Attachment 2.1(b) (the “
Licensed IP Rights ”), and all of Seller’s
rights under all patents, know how and other intellectual property
rights contained in the license
5
agreements included as part
of the Assumed Contracts, subject to any restrictions and
obligations in such license agreements. Seller hereby retains a
royalty-free right and license under the Licensed IP Rights for use
in the Business, solely to the extent necessary for, and solely for
the purposes of, performing Seller’s obligations under this
Agreement and the Transition Services Agreement, and only until the
completion of Seller’s obligations hereunder and
thereunder.
(c) Trademark
Registrations . Upon Closing, Seller shall sell, transfer,
assign, convey and deliver; or shall cause to be sold, transferred,
assigned, conveyed and delivered to Buyer, all of Seller’s
rights, title and interest in and to the Trademarks, trademark
registrations and applications which are identified in
Attachment 2.1(c) , together with (i) all common law
rights to the Trademarks, (ii) the goodwill of the Business
symbolized by the Trademarks, (iii) all causes of actions,
claims and demands or other rights for, or arising from any
infringement, dilution, unfair competition, or other violation,
including past infringement, dilution, unfair competition, or other
violation, of the Trademarks, and (iii) all rights
corresponding thereto throughout the world (the “
Trademark Registrations ”). No rights under any other
names are transferred to Buyer hereunder.
(d) Copyrights . Upon
Closing, Seller shall sell, transfer, assign, convey and deliver;
or shall cause to be sold, transferred, assigned, conveyed and
delivered to Buyer, all of Seller’s rights, title and
interest in and to the copyrights, including all related
registrations, applications and common law rights, in any labels,
product marketing materials or other copyrighted works related to
the Product and used in the Business.
(e) Registrations .
Upon Closing, Seller shall sell, transfer, assign, convey and
deliver; or shall cause to be sold, transferred, assigned, conveyed
and delivered to Buyer, solely to the extent saleable,
transferable, assignable, conveyable or deliverable under
applicable law, all of Seller’s rights, title and interest in
and to the regulatory files and approvals, registrations and
governmental authorizations, each NDA, each IND, compliance
notices, licenses and permits, and any applications to the FDA or
the comparable foreign law or bodies in effect or pending at the
Closing Date, and all materials and information relating to the FDA
and other Governmental Entity approvals for the Product in the
Business held by Seller, the same being identified in Attachment
2.1(e) , and all information contained therein (the “
Registrations ”).
(f) Product-Specific
Manufacturing Information . Upon Closing, Seller shall sell,
transfer, assign, convey and deliver; or shall cause to be sold,
transferred, assigned, conveyed and delivered to Buyer all of
Seller’s rights, title and interest in and to all of
Seller’s manufacturing information (the “
Product-Specific Manufacturing Information ”) used
solely and exclusively in the Business. Seller shall retain a
non-exclusive license to use Product-Specific Manufacturing
Information, solely for purposes of fulfilling its obligations
under this Agreement and the Transition Services Agreement, and
only until completion of Seller’s obligations hereunder and
thereunder.
(g) Non Product-Specific
Manufacturing Information . Upon Closing, Seller shall grant,
or shall cause to be granted to Buyer, a perpetual, paid up,
irrevocable, royalty-free, non-exclusive license, with the right to
sublicense, to use, only in the Business, any manufacturing
information that is used by Seller both in the Business and also in
other business activities of Seller (the “ Non-Product
Specific Manufacturing Information ”). Seller shall
retain a non-exclusive license to use Non-Product-Specific
Manufacturing Information in other business activities of
Seller.
6
(h) Research and
Development Materials . Upon Closing, Seller shall sell or
shall cause to be sold, and shall promptly deliver or cause to be
delivered to Buyer, copies of research and development reports and
disclosure memoranda owned or controlled by Seller or its
Affiliates and any of their respective agents, solely to the extent
relating exclusively to the Business (the “ Research and
Development Materials ”).
(i) Marketing and
Promotional Documents . Upon Closing, Seller shall sell, or
shall cause to be sold, and shall thereafter promptly deliver or
cause to be delivered to Buyer, hard copies and an electronic copy
existing and in use as of the Closing Date of the marketing and
promotional documents owned by Seller or its Affiliates, such as
customer lists, marketing and promotional plans, documents and
materials, field force training manuals and materials, and the
like, solely to the extent relating exclusively to the Business
(the “ Marketing and Promotional Documents ”).
Buyer’s use of the Marketing and Promotional Documents shall
be subject to Section 10.6.
(j) Worldwide Safety
Reports . Upon Closing, Seller shall sell, transfer, assign,
convey and deliver or shall cause to be sold, transferred,
assigned, conveyed and delivered to Buyer, a copy of all worldwide
safety reports in the possession of Seller or its Affiliates with
respect to the API or the Product in existence as of the Closing
(the “ Worldwide Safety Reports ”).
(k) Clinical Data .
Upon Closing, Seller shall sell, transfer, assign, convey and
deliver or shall cause to be sold, transferred, assigned, conveyed
and delivered to Buyer, a copy of all clinical data contained in
Seller’s databases referring to the API or the Product (the
“ Clinical Data ”).
(l) Tangible Assets .
Upon Closing, Seller shall sell, transfer, assign, convey and
deliver or shall cause to be sold, transferred, assigned, conveyed
and delivered to Buyer, certain tangible assets, as listed in
Attachment 2.1(l) (the “ Tangible Assets
”).
(m) Domain Names .
Upon Closing, Seller shall sell, transfer, assign, convey and
deliver or shall cause to be sold, transferred, assigned, conveyed
and delivered to Buyer, all of Seller’s rights, title and
interest in and to the domain names listed in Attachment
2.1(m) (collectively, the “ Domain Names
”).
(n) Product Inventory
. Upon Closing, Seller shall sell, transfer, assign, convey and
deliver or shall cause to be sold, transferred, assigned, conveyed
and delivered to Buyer, the Product Inventory.
(o) Packaging
Inventory . Upon Closing, Seller shall sell, transfer, assign,
convey and deliver or shall cause to be sold, transferred,
assigned, conveyed and delivered to Buyer, all packaging material
for the Product, including all package labels and product inserts
used in connection with the Product owned or controlled by Seller
as of the Closing (the “ Packaging Inventory
”).
7
(p) Raw Materials and
WIP . Upon Closing, Seller shall sell, transfer, assign, convey
and deliver or shall cause to be sold, transferred, assigned,
conveyed and delivered to Buyer, the Raw Materials and
WIP.
(q) Assumed Contracts
. Upon Closing, except as otherwise provided in Section 8.4
with respect to the Shared Contracts listed in Attachment
2.1(q)(1) , Seller shall sell, transfer, assign, convey and
deliver or shall cause to be sold, transferred, assigned, conveyed
and delivered to Buyer, all rights and benefits of Seller in
existence as of the Closing Date arising after the Closing Date
under the contracts listed in Attachment 2.1(q)(2) (the
“ Assumed Contracts ”), including, any
intellectual property rights therein.
(r) Books and Records
. Upon Closing, Seller shall deliver to Buyer, copies of all Books
and Records.
(s) Customer Orders .
Upon Closing, Seller shall sell, transfer, assign, convey and
deliver or shall cause to be sold, transferred, assigned, conveyed
and delivered to Buyer, all unfilled Customer Orders as of the
Closing Date (i.e. Customer Orders to the extent that (i) the
Packaged Products at issue have not been shipped to the applicable
customer as of the Closing Date and (ii) Buyer (rather than
Seller or any of its Affiliates) would be paid by the applicable
customer after shipment by Buyer following the Closing Date), a
list of which shall be provided to Buyer within ten
(10) business days after the Closing Date.
2.2 Excluded Assets .
Buyer hereby acknowledges that Seller is not transferring hereunder
any assets, rights or interests of Seller (collectively, the
“ Excluded Assets ”) not specifically set forth
in Section 2.1, including, without limitation:
(a) any contracts or
agreements with any third party that are not Assumed
Contracts;
(b) any assets or rights used
solely in the research, development, manufacture, control,
packaging or release, marketing or sale of products other than the
Product;
(c) any assets or rights,
including without limitation, technical information and
intellectual property, that are not used exclusively in the
Business and are used in other business activities of Seller;
provided that Seller’s failure to sell and transfer such
assets or rights to Buyer would not have any adverse effect on
Buyer’s ability to operate the Business;
(d) equipment, computer
software, and computer hardware, except as listed on Attachment
2.1(l) ;
(e) all Accounts Receivable
arising prior to the Closing Date; and
(f) Corporate records
(financial records, internal correspondence, formation documents,
stock records, board resolutions and minutes, and the
like).
2.3 Assumed
Liabilities . Buyer shall assume and agree to honor, pay and
discharge when due only the following Liabilities of Seller (the
“ Assumed Liabilities ”):
8
(a) all Liabilities of Seller
under the Assumed Contracts, but only to the extent such
Liabilities arise from any event, circumstance or condition
occurring after the Closing Date;
(b) all Liabilities of Seller
under the Registrations to be performed on or after the Closing
Date, but only to the extent such Liabilities relate to any event,
circumstances or conditions occurring after the Closing Date;
and
(c) all other Liabilities
solely to the extent such Liabilities are incurred or relate to
actions or activities occurring after the Closing Date (other than
the Excluded Liabilities listed in Section 2.4) arising out of
or related to the Assets, including, without limitation, any
product liability, product warranty, product return, charge-back,
rebate or Medicaid, Medicare or other reimbursements, or similar
claim, related to the Product sold after the Closing
Date.
2.4 Excluded
Liabilities . The Excluded Liabilities shall remain the sole
responsibility of and shall be retained, paid, performed and
discharged solely by Seller. The “Excluded Liabilities”
shall mean every Liability of Seller other than the Assumed
Liabilities, including, without limitation:
(a) all Taxes that result
from or have accrued in connection with the operation of the
Business prior to the Closing Date;
(b) any Liability or
obligation of Seller of any nature owed to any employees,
directors, former employees, agents or independent contractors,
whether or not employed by Buyer after the Closing, that
(A) arises out of or relates to the employment or service
provider relationship between Seller and any such individual(s)
(including, but not limited to, claims for compensation,
discrimination, harassment, or retaliation); or (B) arises out
of or relates to events or conditions occurring on or before the
Closing Date (including the transactions contemplated by this
Agreement);
(c) all Accounts Payable
arising prior to the Closing Date;
(d) Liabilities of Seller
relating to actions or activities of Seller or its Affiliates or
any of their respective employees or agents relating to the
Business that occurred prior to the Closing Date;
(e) Liabilities of Seller
under the Assumed Contracts that were incurred or arose prior to
the Closing Date;
(f) Liabilities of Seller
under the Shared Contracts that relate to products or businesses of
Seller other than the Product or the Business or that a
|